Ksb D03 K0014

Regulatory References

• ICH-E2A
• EMA-GVP-014
• EMA-GVP-015

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in psychiatric effects
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (ICH-E2A, EMA-GVP-014, EMA-GVP-015)
4. Connect to related EPAs: EPA-01, EPA-02, EPA-05

Key Competencies

• Depression, anxiety, psychosis, suicidal ideation, behavioral changes

Assessment Criteria

• Can explain core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D03 skills in Neurological and Psychiatric ADRs
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31